Asteria Health Recalls Estradiol 15 mg Sterile Pellets Due to Potential Metal Contamination
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F.H. INVESTMENTS, Inc. (dba Asteria Health) is voluntarily recalling 14,848 Estradiol 15 mg sterile pellets nationwide due to the potential presence of metal particulate matter.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
F.H. INVESTMENTS, Inc., doing business as Asteria Health, has initiated a voluntary recall of Estradiol 15 mg sterile pellets. The recall was prompted by the potential presence of a foreign substance, specifically metal particulate matter, within the product. This Class II recall was officially classified by the FDA on February 11, 2026.
Which Products Are Affected
The recall affects 14,848 units of ESTRADIOL, 15 mg, 1 Sterile Pellet. The product is identified by NDC 79559-3015-32 and was distributed nationwide in the United States. The following lot numbers and expiration dates are included in the recall:
- Lot#: 253000118, Exp. 02/21/2026
- Lot#: 253000145, Exp. 08/02/2026
- Lot#: 253000146, Exp. 06/30/2026
- Lot#: 253000167, Exp. 09/23/2026
What You Should Do
Healthcare providers and consumers should immediately stop using the affected lots. Asteria Health began notifying customers of the issue via letter on January 26, 2026. For information regarding product returns or to report concerns, contact the firm at 432 Industrial Ln, Birmingham, AL 35211.
Why This Matters
The presence of metal particulate matter in a sterile drug product intended for administration poses a serious health risk, as it can lead to internal injury or adverse physiological reactions.
Source
Recall information provided by the FDA (Recall Number: D-0310-2026).
Original source: FDA Official Notice ↗
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